A randomized phase II trial of two different four-drug combinations in advanced pancreatic adenocarcinoma: Cisplatin, capecitabine, gemcitabine plus either epirubicin or docetaxel

4614 Background: The combination of cisplatin (P), epirubicin (E), 5-fluorouracil (F) and gemcitabine (G) (PEFG regimen) yielded a progression-free survival at 6 months from treatment start (PFS6) of about 50% and a 1-year overall survival (OS) around 40% in patients with advanced pancreatic adenocarcinoma (PA). The current trial was aimed to assess whether the replacement of E with docetaxel (D) may improve PFS6. Methods: Chemo-naive patients with stage III or metastatic PA, age 18–75y, Karnofsky performance status (PS) >50 received P (30 mg/m2 day 1), G (800 mg/m2 day 1) and capecitabine (1250 mg/m2/day days 1 to 14) and were randomized to receive either D at 25–30 mg/m2 day 1 (arm A: PDXG regimen) or E at 30 mg/m2 day 1 (arm B: PEXG regimen). Cycles were repeated every 14 days for a maximum of 6 months. Tumor was assessed by CT scan every 8 weeks. The Fleming design was used to calculate the sample size on the probability of being PFS6 (primary endpoint). Assuming P0=40% and P1=60%, α .05 and β.10, the...